Since establishment of Clinical Trial Unit (CTU) in 1997, to now the Investigational Medicine Unit (IMU), the unit has many experiences in conducting clinical trials, ranging from Phase I to Phase IV post market studies. While IMU team puts in our best in every study, there are several studies which the team had excelled exceptionally in terms of patient recruitment, quality work and providing strong support to the investigators and sponsors.
FIRST-IN-MAN H5N1 VACCINE
IMU’s first First-In-Man H5N1 Vaccine trial. The trial was conducted in year 2016, sponsored by Baxter . Findings from this clinical trial was published in the New England Journal of Medicine (http://www.nejm.org/doi/full/10.1056/NEJMoa073121).
IMU had successfully recruited 16 subjects for this study.
FIRST MADE-IN-SINGAPORE ORAL ANTI-DIABETIC DRUG BY INVESTIGATOR INITIATED TRIAL (IIT)
This Phase I clinical study exemplifies a successful tripartite partnership, comprising NUS Yong Loo Lin School of Medicine, NUHS IMU and Singapore Clinical Research Institute (SCRI).
This tripartite collaboration is noteworthy for:
- A first made-in-Singapore oral anti-diabetic drug, which improves the action of insulin and reduces risks of diabetes-related complications.
- The investigational product (DAA-1) is developed in National University of Singapore, unlike most other trials where the investigational drugs are developed by the pharmaceutical companies.
- Unlike traditional pharma-funded trials, this is a tripartite joint effort between 3 healthcare research partners in Singapore.
- This is the first public (NMRC) funded “Made in Singapore” drug to have completed the Phase 1 study in NUHS IMU (Singapore).
The study article was first published in the Journal, Drugs in R & D on 28 September 2016, with open access at Springerlink.com. The journal Impact Factor is at 4.633. There was a media release/interview held on 20 Oct 2016 to brief the media of possibly the first oral anti-diabetic drug discovered and developed in Singapore.
IMU supported the research studies/projects under the SPRINT TB (Singapore Programme of Research Investigating New Approaches to Treatment of Tuberculosis) – a Singapore-based comprehensive bench-to-bedside research programme focused on creating, developing and delivering new improved treatments for tuberculosis (TB). This flagship programme is funded by the National Medical Research Council (NMRC), Singapore. This award indicates the recognition of the importance of tuberculosis (TB) as a major public health threat, especially in Asia, as well as for Singapore researchers to make a pivotal contribution in this area of healthcare.
FIRST IN ASIA TO MEET PATIENT RECRUITMENT TARGET FOR DENGUE VACCINE STUDY
The Dengue Vaccine Study is a Phase II global sponsored study. IMU reached the recruitment target of 300 patients in 6 months, making us the first site in Asia to meet the recruitment target and fastest to complete recruitment.
INVIRAGEN’S FIRST CLINICAL TRIAL FOR ITS PROPRIETARY HAND, FOOT, MOUTH DISEASE (HFMD) VACCINE
Inviragen’s FIH phase I study on HFMD was conducted at IMU under Inviragen’s memorandum of understanding with Duke-NUS Graduate Medical School.
The study was initiated rapidly and was completed in six months. A total of 16 healthy volunteers was recruited, meeting the initial recruitment target set for IMU.
Link: CHIP Trial
LARGEST PI-INITIATED TRIAL USING ONLINE RECRUITMENT PORTAL – THE CHIP TRIAL
The CHloroquiune for Influenza Prevention (CHIP) Trial is a randomized, double-blind, placebo controlled trial of chloroquine for the prevention of influenza: evaluation of its clinical pharmacology and relationship between drug levels and protective efficacy.
It is the largest PI Initiated clinical trial IMU had supported till date, with IMU’s entire team of study coordinators involved to support recruitment and management of the trial. 1,500 subjects were recruited using the online portal.